Coronary artery disease (CAD) and angina Circulatory System
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: as per current SmPC 1. Patients 18 years and older 2. Female or male 3. Patients with documented stable coronary artery disease with or without left ventricular dysfunction (LVD); example: with angina, history of revascularization, history of myocardial infarction, or angiographic evidence of at least 70% stenosis of one of the major coronary arteries 4. Patient with stable angina diagnosed more than 6 months ago 5. HR resting >70 bpm 6. Patients inadequately controlled despite an optimal dose of beta-blockers
Exclusion criteria
Exclusion criteria: Exclusion criteria: according to current SmPC 1. Known hypersensitivity to the active substance or any of the excipients 2. Resting heart rate of fewer than 70 beats per minute prior to treatment 3. Cardiogenic shock 4. Acute myocardial infarction 5. Severe hypotension (<90/50 mmHg) 6. Severe liver failure 7. Sick sinus syndrome 8. Atrial sinus block 9. Unstable or acute heart failure 10. Pacemaker-dependent patient (heart rate exclusively imposed by the pacemaker) 11. Unstable angina 12. Third-degree atrioventricular (AV) block 13. Combination with potent cytochrome P450 3A4 inhibitors, such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), protease inhibitors (nelfinavir, ritonavir) or nefazodone 14. Combination with verapamil or diltiazem, moderate CYP 3A4 inhibitors with bradycardic effects 15. Pregnancy, breastfeeding and women of childbearing age not using effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. HR measured by electrocardiogram at baseline, after 1 month and after 4 months 2. CCS grades determined using the Canadian Cardiovascular Society grading of angina pectoris system at baseline, after 1 month and after 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Physician satisfaction assessed by rating the tolerability, efficacy, and effectiveness of ivabradine on a scale of 0 to 5 after 4 months of ivabradine treatment | — |
Countries
Morocco